The Controversy over Guidant's Implantable Defibrillators
Tags: PRODUCT liability -- Medical instruments & apparatus; IMPLANTABLE cardioverter-defibrillators; IMPLANTED cardiovascular instruments; GUIDANT Corp.; OUKROP, Joshua; MANUFACTURING industries -- Defects
- Guidant criminally charged with concealing information from FDA. YOFFEE, LYNN // Medical Device Daily;2/26/2010, Vol. 14 Issue 38, p1
The article discusses the alleged violations by cardiac rhythm management firm Guidant. The violations were related to electrical flaws in its implantable cardioverter defibrillators (ICD), which led to charges filed by the Department of Justice (DOJ) in the federal district court in St. Paul,...
- Guidant Panel's Advice May Help Beyond ICDs. // Medical Design Technology;Oct2005, Vol. 9 Issue 11, p9
The article reports that an independent panel created by Guidant Corp. is set to conduct a case study on the company's handling of implantable cardioverter defibrillator (ICD) safety communications by February 2006. While the study will focus on the company's ICD business, the panel is hoping...
- Unraveling the Secrets of the Heart. Mraz, Stephen J.; Knisley, Stephen B.; Baynham, Tamara C. // Machine Design;09/24/98, Vol. 70 Issue 17, p38
Provides information on automatic implantable cardioverter/defibrillators, a medications and electronic device that shaped and positioned electrodes on heart fibers. Structure and electrical behavior of the heart; Simulation and analysis of the device.
- A diagnostic pitfall with an implantable cardioverter-defibrillator. Burri, H.; Chevalier, P.; Touboul, P. // Heart;Apr2003, Vol. 89 Issue 4, p470
Describes the case of a diagnostic pitfall in a patient with an implantable cardioverter-defibrillator. Admission of the patient to the hospital due to repeated shocks from his Guidant Ventak Prizm dual chamber implantable cardioverter-defibrillator.
- Fatalities and failures prompt recall of cardiac defibrillators. // Consumer Reports;Sep2005, Vol. 70 Issue 9, p11
Reports that two deaths and dozens of product failures have led to a worldwide recall of tens of thousands of cardiac defibrillators designed by the Guidant Corp., which have been implanted in patients susceptible to dangerous abnormal heart rhythms. Review of how the devices are designed to...
- 303 Patients with implantable cardioverter defibrillator and their experiences of shocks. Stromberg, A.; Hammargard, J.; Fant, D.; Johansson, I. // European Journal of Heart Failure. Supplements;Jun2007 Supplement 1, Vol. 6, p66
An abstract of the study "Patients With Implantable Cardioverter Defibrillator and Their Experiences of Shocks," by A. Stromberg and colleagues, is presented.
- Implantierbarer Kardioverter/Defibrillator. Stellbrink, C.; Andresen, D.; Böcker, D.; Lewalter, T. // Herzschrittmachertherapie und Elektrophysiologie;Mar2013, Vol. 24 Issue 1, p75
This article aims to give an overview over important articles in the field of implantable cardioverter defibrillator (ICD) therapy in 2012. Important publications concern analyses on therapy efficacy and safety of the subcutaneous ICD, gender-specific differences in the complication rate and...
- Stuck with the check? Becker, Cinda // Modern Healthcare;6/27/2005, Vol. 35 Issue 26, p20
Reports on the recall of implantable cardiac defibrillators (ICD) by Guidant Corp. in the U.S. in June 2005. Cost of the device; Background on ICD; Problems encountered by patients at Indiana Heart Hospital in Indianapolis with the device.
- ICD Leads and Postmarketing Surveillance. Carlson, Mark D. // New England Journal of Medicine;3/8/2012, Vol. 366 Issue 10, p967
The article offers responses by St. Jude Medical (SJM) to assertions in an article about the company's implantable cardioverter defibrillator (ICD) leads and postmarketing surveillance. SJM reportedly has conducted extensive bench and short-term studies. It has also created prospective, actively...